Research Design, Compliance and Data Management

What is the specific question that you are trying to answer? The type of data that you need to collect: Do you need quantitative data or qualitative data? Do you need to collect new data from subjects, or will you use existing data? Do you plan to conduct a cohort study, a case-control study, or randomized controlled trial? Do you have the time, money, and personnel to conduct a study designed with adequate power and sample size? The ethical considerations: Are there any ethical issues that need to be considered, such as the safety and well-being of participants? By carefully considering these factors, RDCD core can assist you with choosing a research design that will help you to answer your research question effectively and ethically.

Some examples of statistical support offered include hypothesis testing (t-tests, ANOVA, or chi-square), correlation analysis, regression analysis, and factor analysis for clinical trials and epidemiological studies. We also offer advanced analyses, including causal inference, spatial analysis of image mass cytometry data, and data integration of omics data with treatment/exposure and clinical outcomes.

In essence, RDCD statistical support involves using statistical methods to collect, analyze, interpret, and present data in a way that is meaningful, reliable, and valid.

The RDCD core has expertise in using Cerner Real-World Data (CRWD), a de-identified multi-center electronic health records database, providing a comprehensive view of patient information and supporting efficient healthcare delivery and data analysis. The core also has experience with other databases, such as Kentucky Medicaid projects, SEER Medicare projects, SPHIS purchased Kentucky hospital databases, and the National Health and Nutrition Examination Survey (NHANES).

The RDCD provides assistance in areas like IRB office procedures, CITI program training, and human subjects protection. RDCD core also provide assistance creating databases and using REDCap, led by the Clinical Trails Unit.

The RDCD core has expertise in providing training and guidance on research design, data analyses, compliance and data management.

• The RDCD core has expertise in using Cerner Real-World Data™ (CRWD), a de-identified multi-center electronic health records database. They utilize the Real-World Data Core Model, which provides a comprehensive view of patient information and supports efficient healthcare delivery and data analysis.
• The core also has experience with other databases, such as Kentucky Medicaid projects, SEER Medicare projects, SPHIS purchased Kentucky hospital databases, and the National Health and Nutrition Examination Survey (NHANES).

• The RDCD provides support in areas like IRB office procedures, CITI program training, and human subjects protection.
• They create databases using REDCap, led by Clinical Trial Units.

• The RDCD is involved in establishing the University of Louisville Data Warehouse, which will house de-identified UofL Research Data. This will require careful access control and data management procedures to ensure compliance and data security.

• The RDCD core actively collaborates with other LCTRC cores, including HR, CEO, PD, Admin Core, ULH IT, and UofL IT.
• They provide training on study design, compliance, and data management in collaboration with the PD core.
• The RDCD core is involved in developing protocols for creating the UofL research data warehouse.
• They support the initiative to establish the UofL biorepository catalog.